Indirect Efficacy Claims for Monkeypox – Hard Surface Disinfectants
By: Jacqui Jenskey, Principal Regulatory Affairs Consultant, email
On July 23, 2022, the WHO declared the monkeypox outbreak to be a public health emergency of international concern. Monkeypox viruses are enveloped viruses. Enveloped viruses are one of the easiest to kill with an appropriate disinfectant product compared to non-enveloped viruses. Monkeypox belongs to the Poxviridae family, part of the same family of viruses as the variola virus, the virus that causes smallpox.
Because non-enveloped viruses are more resistant to surface disinfectants than enveloped viruses, surface disinfectants that are effective against non-enveloped viruses are expected to also be effective against enveloped viruses.
Therefore, drug identification number (DIN)-authorized disinfectants with approved claims as either a “broad spectrum virucide” or with a specific claim against a non-enveloped virus, such as adenovirus type 5, bovine parvovirus, canine parvovirus, and poliovirus type 1, will be permitted to make indirect efficacy claims against the monkeypox virus.
ONLY indirect claims will be permitted for the monkeypox virus, such as “expected to be effective” and “likely to be effective”. Direct claims against the monkeypox virus CANNOT be made. The following are examples of acceptable wording for indirect communications related to monkeypox:
- “DIN-approved disinfectants which have received market authorization for a “broad spectrum virucide” claim (i.e., have proven efficacy against a hard-to-kill non-enveloped virus) or a specific claim against a non-enveloped virus are expected to inactivate less resistant enveloped viruses, such as monkeypox. Therefore, in choosing a hard surface disinfectant to be used against monkeypox, any disinfectant with a “broad spectrum virucide” claim or a specific claim against a non-enveloped virus would be appropriate, as it would be expected to also inactivate the monkeypox”
- “This product (insert Product Name) is a broad-spectrum virucidal hard surface disinfectant that is expected to inactivate the monkeypox virus”
- “Kills (insert surrogate virus name) and is likely to kill the monkeypox virus”
- “Effective against (insert surrogate virus name) and likely to kill the monkeypox”
- “This product has demonstrated effectiveness against (insert surrogate virus name) and is expected to inactivate the monkeypox”
An indirect claim can be added to your label through a Post DIN Change (PDC) which has no Health Canada cost associated with it and takes 30 days to be processed.
Let us know if Dell Tech can help you submit your PDC to have this claim added to your product.
Principal Regulatory Affairs Consultant
519-858-5021 x 2028
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